Cl II CARESTREAM DRX-EVOLUTION X-Ray system

Company:Carestream Health Inc.
Date of Enforcement Report: 9/2/2015
Class lI:

PRODUCT

CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015

REASON
Carestream became aware of an issue with its DRX Evolution System v5.7 DIRECTVIEW Software v5.6 and v5.7. It has been determined that there is a software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

RECALLING FIRM/MANUFACTURER
Carestream Health Inc, Rochester, NY on 8/7/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
Domestic: 76 units, Foreign: 160 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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